Synthetic Estrogen Drug Receives FDA Approval In 1.25mg Strength

Duramed Pharmaceuticals announced March 13 that the United States Food and Drug Administration (FDA) has approved the company's supplemental new drug application for Cenestin tablets in the 1.25 mg dosage strength. Cenestin, which was awarded FDA approval for the 0.625 mg and 0.9 mg strengths last year is Duramed's plant-derived, synthetic conjugated estrogens product for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. The drug presents an alternative for women who currently receive conjugated estrogens derived from horse urine. (See http://www.thehorse.com/ViewArticle.aspx?ID=738, a March, 1997 article which examined the welfare of pregnant mare urine (PMU) ranching).

The addition of the 1.25 mg strength tablet to the Cenestin family provides a physician more complete dosing flexibility. Manufacturing of the 1.25 mg dosage has begun at Duramed's Cincinnati, Ohio manufacturing facility and distribution will commence immediately.

The conjugated estrogens market was estimated to be $1.4 billion in 1998. With this approval, Cenestin now is available in dosage strengths used by more than 95 percent of the women receiving conjugated estrogens, giving them a plant-based alternative for the treatment of moderate-to-severe vasomotor symptoms.

Duramed successfully completed clinical trials in July 1999 that established the bioequivalence of one 1.25 mg strength tablet of Cenestin to two of the approved 0.625 mg Cenestin Tablets.

About the Author

Stephanie L. Church, Editor-in-Chief, received a B.A. in Journalism and Equestrian Studies from Averett College in Danville, Virginia. A Pony Club and 4-H graduate, her background is in eventing, and she is schooling her recently retired Thoroughbred racehorse, Happy, toward a career in that discipline. She also enjoys traveling, photography, cycling, and cooking in her free time.

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